TY - JOUR
T1 - Phase II study of epirubicin in combination with weekly docetaxel for patients with advanced nsclc who have failed or relapsed after the frontline platinum-based chemotherapy
AU - Lin, Chih Ming
AU - Chen, Chih Hung
AU - Chang, John Wc
AU - Tsao, Thomas Cy
PY - 2009/4
Y1 - 2009/4
N2 - BACKGROUND:: We conducted a phase II study to evaluate the efficacy and toxicity of weekly docetaxel combined with epirubicin on D15 as second-line chemotherapy in Taiwanese patients with advanced non small cell lung cancer (NSCLC) who failed or relapsed after the frontline platinum-based chemotherapy. PATIENTS AND METHODS:: Patients with histologically confirmed advanced NSCLC (Stage IIIB-IV) were entered into this Phase II trial. Eastern Cooperative Oncology Group performance status was 0 to 2 and adequate organ function was required. Docetaxel, 30 mg/m, was given intravenously on days 1, 8, and 15 for 30 minutes and epirubicin, 60 mg/m, was given intravenously on day 15, then following one week of rest. Treatment was repeated every 4 weeks for a maximal total of 6 cycles. RESULTS:: Of the 43 eligible patients, 39 patients were evaluated for response, and all were evaluated for toxicity. The overall response rate was 11.6% [95% confidence interval (CI), 1.6-21.6%]. The median time to disease progression for all patients was 2.8 months (95% CI 1.3-4.3%). The median survival time for all patients was 7.7 months (95% CI 5.5-9.9%). The 1-year survival was 32.6% (95% CI 25.4%-39.7%). The major hematologic toxicities were neutropenia, 8/43 (19%) with grade 3-4 neutropenia, as well as anemia, 6/43 (14%) with grade 3-4 anemia. Nonhematological toxicities were modest. Fatigue was common, 77.8% in all, but only 3 (7%) patients with grade 3-4 toxicities. Diarrhea was also common but not severe, 7/43 (16%) with grade 1-2 episodes, and 1/43 (2%) with grade 3-4 episodes. Nail changes, peripheral edema, lacrimation, and alopecia were mild. Hepatic and renal impairment was also only mild. CONCLUSION:: Combining weekly doses of docetaxel 30 mg/m with epirubicin 60 mg/m on D15 was not shown to improve both efficacy and tolerability for advanced NSCLC patients who have relapsed disease after frontline platinum-based chemotherapy.
AB - BACKGROUND:: We conducted a phase II study to evaluate the efficacy and toxicity of weekly docetaxel combined with epirubicin on D15 as second-line chemotherapy in Taiwanese patients with advanced non small cell lung cancer (NSCLC) who failed or relapsed after the frontline platinum-based chemotherapy. PATIENTS AND METHODS:: Patients with histologically confirmed advanced NSCLC (Stage IIIB-IV) were entered into this Phase II trial. Eastern Cooperative Oncology Group performance status was 0 to 2 and adequate organ function was required. Docetaxel, 30 mg/m, was given intravenously on days 1, 8, and 15 for 30 minutes and epirubicin, 60 mg/m, was given intravenously on day 15, then following one week of rest. Treatment was repeated every 4 weeks for a maximal total of 6 cycles. RESULTS:: Of the 43 eligible patients, 39 patients were evaluated for response, and all were evaluated for toxicity. The overall response rate was 11.6% [95% confidence interval (CI), 1.6-21.6%]. The median time to disease progression for all patients was 2.8 months (95% CI 1.3-4.3%). The median survival time for all patients was 7.7 months (95% CI 5.5-9.9%). The 1-year survival was 32.6% (95% CI 25.4%-39.7%). The major hematologic toxicities were neutropenia, 8/43 (19%) with grade 3-4 neutropenia, as well as anemia, 6/43 (14%) with grade 3-4 anemia. Nonhematological toxicities were modest. Fatigue was common, 77.8% in all, but only 3 (7%) patients with grade 3-4 toxicities. Diarrhea was also common but not severe, 7/43 (16%) with grade 1-2 episodes, and 1/43 (2%) with grade 3-4 episodes. Nail changes, peripheral edema, lacrimation, and alopecia were mild. Hepatic and renal impairment was also only mild. CONCLUSION:: Combining weekly doses of docetaxel 30 mg/m with epirubicin 60 mg/m on D15 was not shown to improve both efficacy and tolerability for advanced NSCLC patients who have relapsed disease after frontline platinum-based chemotherapy.
UR - http://www.scopus.com/inward/record.url?scp=67749129531&partnerID=8YFLogxK
U2 - 10.1097/COC.0b013e31817eebdc
DO - 10.1097/COC.0b013e31817eebdc
M3 - 文章
C2 - 19307958
AN - SCOPUS:67749129531
SN - 0277-3732
VL - 32
SP - 169
EP - 173
JO - American Journal of Clinical Oncology: Cancer Clinical Trials
JF - American Journal of Clinical Oncology: Cancer Clinical Trials
IS - 2
ER -
